Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT03421834
Eligibility Criteria:
Inclusion Criteria:
1. Ischemic cardiomyopathy with reduced ejection fraction (EF ≤ 40%) estimated by cardiac MRI or echocardiography within 30 days before enrollment
2. Coronary Chronic Total Occlusion (CTO) associated with a previous MI confirmed by coronary angiography and late gadolinium enhancement MRI or myocardial perfusion imaging within 30 days before enrollment
3. Implantable cardioverter-defibrillator (ICD) indication for primary prevention
4. Patient has provided written informed consent
Exclusion Criteria:
1. Age \< 18 years or \> 85 years
2. Documented sustained ventricular tachycardia before enrollment
3. Class IV New York Heart Association (NYHA) heart failure
4. CTOs not associated with a prior infarction in their territory
5. Acute myocardial infarction (MI) or acute coronary syndrome
6. Subjects with active ischemia that are eligible for revascularization
7. Documented history of MI less than 6 months before enrollment
8. Patients requiring chronic renal dialysis
9. Thrombocytopenia or coagulopathy
10. Pre-existing implantable cardioverter-defibrillator (ICD)
11. Pregnancy or breastfeeding women
12. Acute illness or active systemic infection
13. Life expectancy less than 12 months
14. Unwillingness to participate or lack of availability for follow-up
15. Valvular heart disease or mechanical heart valve precluding access to the left ventricle
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03421834
Study Brief:
Protocol Section:
NCT03421834